Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Ketorolac Tromethamine Injection
cGMP Deviations: deviations leading to potential cross-contamination.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
PF-0.125% Bupivacaine HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Trisodium Citrate 0.5% Solution
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class III · Low risk
Timolol Maleate Ophthalmic Solution
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Class II · Moderate risk
Corsair Personal Care 99X Instant Foam Hand Sanitizer
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class II · Moderate risk
Maxim Instant Foam Hand Sanitizer
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class III · Low risk
Nighttime Sleep-Aid
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class III · Low risk
Acetaminophen 500 mg tablet
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class III · Low risk
Acetaminophen 325 mg tablets
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class II · Moderate risk
Acetaminophen Injection
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class III · Low risk
Zynrelef (bupivacaine and meloxicam)
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion 0.05%
Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk
PrednisoLONE Oral Solution USP
Defective Container: Product has incomplete induction seals.
Class I · High risk
Banana Boat hair & scalp defense
Chemical contamination: presence of benzene
Class II · Moderate risk
Rifampin Capsules
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II · Moderate risk
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Lack of Assurance of Sterility
Class II · Moderate risk
Divalproex Sodium Extended Release Tablets
Failed dissolution specifications.
Class III · Low risk
Azacitidine for Injection
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate in 0.9% Sodium Chloride
Lack of Assurance of Sterility